FDA Orange Book

Generic for Cozaar

Cozaar contains losartan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Cozaar is losartan. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Cozaar products in the Orange Book

Cozaar products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	100MG	Marketed (Rx)	AB	16	AB
tablet, oral	25MG	Marketed (Rx)	AB	16	AB
tablet, oral	50MG	Marketed (Rx)	AB	16	AB

NDA 020386, held by ORGANON LLC A SUB OF ORGANON AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic losartan

Approved generic versions of Cozaar
Company	ANDA	TE code	Approved	Strengths
AIPING PHARMACEUTICAL INC	090544	AB (A-rated, therapeutically equivalent)	October 6, 2010	100MG, 25MG, 50MG
ALEMBIC PHARMACEUTICALS LTD	090428	AB (A-rated, therapeutically equivalent)	October 6, 2010	100MG, 25MG, 50MG
AUROBINDO PHARMA LTD	090083	AB (A-rated, therapeutically equivalent)	October 6, 2010	100MG, 25MG, 50MG
CHARTWELL RX SCIENCES LLC	077424	AB (A-rated, therapeutically equivalent)	October 6, 2010	100MG, 25MG, 50MG
LUPIN LTD	078232	AB (A-rated, therapeutically equivalent)	October 6, 2010	100MG, 25MG, 50MG
STRIDES PHARMA GLOBAL PTE LTD	090382	AB (A-rated, therapeutically equivalent)	October 6, 2010	100MG, 25MG, 50MG
WATSON LABORATORIES INC	091129	AB (A-rated, therapeutically equivalent)	October 6, 2010	100MG, 25MG, 50MG
ZYDUS PHARMACEUTICALS USA INC	078243	AB (A-rated, therapeutically equivalent)	October 6, 2010	100MG, 25MG, 50MG
PRINSTON PHARMACEUTICAL INC	091497	AB (A-rated, therapeutically equivalent)	June 6, 2011	100MG, 25MG, 50MG
MACLEODS PHARMACEUTICALS LTD	202230	AB (A-rated, therapeutically equivalent)	May 30, 2012	100MG, 25MG, 50MG
JUBILANT CADISTA PHARMACEUTICALS INC	201170	AB (A-rated, therapeutically equivalent)	September 18, 2012	100MG, 25MG, 50MG
HETERO LABS LTD UNIT V	203835	AB (A-rated, therapeutically equivalent)	August 12, 2015	100MG, 25MG, 50MG
UNICHEM LABORATORIES LTD	203030	AB (A-rated, therapeutically equivalent)	October 14, 2015	100MG, 25MG, 50MG
GRANULES INDIA LTD	215959	AB (A-rated, therapeutically equivalent)	February 23, 2023	100MG, 25MG, 50MG
MSN LABORATORIES PRIVATE LTD	217396	AB (A-rated, therapeutically equivalent)	August 14, 2023	100MG, 25MG, 50MG
GRAVITI PHARMACEUTICALS PRIVATE LTD	219859	AB (A-rated, therapeutically equivalent)	September 19, 2025	100MG, 25MG, 50MG

Cozaar NDC codes

Questions

Is there a generic for Cozaar?

Yes. The generic name for Cozaar is losartan. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Cozaar?

The active ingredient in Cozaar is losartan, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.